Category - Recast

medicaldeviceslegal

ENVI vote postponed once more

Compromising is time consuming business, that’s for sure. And sometimes it’s not easy to reach compromises. Apparently the ENVI Committee members were not able to reach compromises timely, because the postponed vote on the medical devices regulation proposals that was scheduled for 18 September has now been … postponed, again. The discussion of the regulation […]

medicaldeviceslegal

ENVI IVD Regulation proposal vote postponed as well

So far it may have looked like the IVD regulation proposal would be put to a vote in the ENVI committee on 10 July because unlike the explicit movement of the date for the vote on the general medical devices regulation proposal the IVD proposal seemed to stay on track. That turns out not to […]

medicaldeviceslegal

EU member states show some of their cards on medical devices revision

The EU member states have so far been the dark horse in the discussions surrounding the revision of the EU medical devices directives, keeping their cards close to their chest and not getting involved in the largely fact free politics surrounding the ENVI rapporteurs’ drafts for the medical devices and IVD regulations. Council of Employment, […]

medicaldeviceslegal

Euro update and Don’t Lose The SME

While the medical devices and IVD regulation proposals trickle through the legislative process and people concentrate on details like I have done on this blog as well, it might be nice to have a higher level picture. So that’s what my UK colleague Alex Denoon and I prepared for a recent webinar, and what we […]

medicaldeviceslegal

ENVI’s 29 may debate on medical devices

The fog of war that I wrote about with respect to the tsunami of amendments is lifting with the discussion of the amendments in the ENVI committee today. It was a very interesting debate, and I’ll share my impression of it with you. I have grouped what I heard by subjects so it’s easier to […]